DOSEVIEW 3D

Accelerator, Linear, Medical

STANDARD IMAGING, INC.

The following data is part of a premarket notification filed by Standard Imaging, Inc. with the FDA for Doseview 3d.

Pre-market Notification Details

Device IDK103193
510k NumberK103193
Device Name:DOSEVIEW 3D
ClassificationAccelerator, Linear, Medical
Applicant STANDARD IMAGING, INC. 3120 DEMING WAY Middleton,  WI  53562 -1461
ContactRaymond T Riddle
CorrespondentRaymond T Riddle
STANDARD IMAGING, INC. 3120 DEMING WAY Middleton,  WI  53562 -1461
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-29
Decision Date2010-12-27
Summary:summary

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